Full Arch Rehabilitations Through the Contemporary All-on-4 Concept
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Prosthetic survival
研究概览
简要总结
It is necessary to generate more evidence on the outcome of contemporary protocols for full-arch rehabilitations supported by implants in immediate function in areas with limited quantity and density bone.
This research project aims to investigate the outcome of fixed prosthetic restorations supported by implants in immediate function for full-arch rehabilitation through the All-on-4 concept contemporary protocol, specifically: implant survival and success, prosthetic survival, marginal bone level and marginal bone level changes, soft tissue health parameters (Plaque index, Bleeding index, Pocket depth), incidence of biological and mechanical complications. A prospective cohort study design will be used in the investigation.
The sample of this study is estimated to consist in 43 patients rehabilitated with full-arch fixed prosthetic rehabilitations supported by implants in immediate function (All-on-4 concept) with 144 dental implants.
The cohort will be evaluated between baseline and 3 years of follow-up.
详细描述
Problem The fixed prosthetic rehabilitation through implants in immediate function is documented without prejudice of the outcome when compared to 2-stage surgery.1 One of the protocols for full-arch fixed prosthetic rehabilitation supported by implants in immediate function is the All-on-Four concept, which is documented with good long-term outcomes in both jaws.
Nevertheless, the protocols suffered a constant evolution throughout the 20 years of development of the All-on-4 concept. Evidence on the outcome full-arch rehabilitations supported by implants in immediate function through the All-n-4 concept contemporary protocol is needed. Therefore, the aim of this study was to document the rehabilitation of com¬pletely edentulous jaws through the contemporary All-on-4 concept rehabilitation protocol.
Objectives
- To evaluate the medium-term outcome (3 years) of full arch rehabilitations supported by implants in immediate function through the contemporary All-on-4 protocol
- To report the results
Study Endpoints Primary endpoint
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with enough bone quantity to be rehabilitated through the contemporary All-on-4 protocol using standard implants (7 to 25 mm of length);
- •Patients that are interested in performing their follow-up and maintenance program at Maló Clinic);
- •Patients that provide written informed consent to participate.
排除标准
- •Patients without enough bone quantity to be rehabilitated with the need of inserting zygomatic implants;
- •Patients that exhibit bone graft reconstructions;
- •Hindrance to provide written informed consent
结局指标
主要结局
Prosthetic survival
时间窗: annually up to 3 years of follow-up
Survival of the implant-supported prosthesis at the end of the follow-up period
Dental implants survival
时间窗: annually up to 3 years of follow-up
Survival of the dental implants at the end of the follow-up period
次要结局
- Marginal bone loss(1-, 2- and 3-years)
- Plaque index(1-, 2- and 3-years)
- Bleeding index(1-, 2- and 3-years)
- Probing pocket depts(1-, 2- and 3-years)